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Measurement of Renal Functional Reserve

Measurement of Renal Functional Reserve With Urinary Clearance of Cold Iothalamate Before and After an Oral Protein Load

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03190070
Enrollment
47
Registered
2017-06-16
Start date
2017-07-12
Completion date
2021-12-01
Last updated
2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Diseases

Keywords

Renal reserve, physiological study, diagnostic testing

Brief summary

Single arm physiological study to measure renal functional reserve as a biomarker of kidney function and health

Detailed description

The investigators will measure glomerular filtration rate using urinary clearance of cold iothalamate before and after an oral protein load in patients with chronic kidney disease and healthy volunteers.

Interventions

DIETARY_SUPPLEMENTIngestion of protein

Oral protein load as a physiological stimulus to temporarily increase glomerular filtration rate

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Physiological study to measure the change in glomerular filtration rate after an oral protein load

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Age ≥18 2. Estimated GFR \>30 mL/min/1.73m2

Exclusion criteria

1. Allergy to iothalamate, shellfish or iodine 2. Use of metformin or amiodarone 3. Inability to maintain a stable regimen of medications which affect GFR for \> one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers) 4. Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim) 5. Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy 6. Inadequate intravenous access 7. Severe anemia (Hct \<21%) 8. Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dL on most recent labs prior to enrollment) 9. History of contrast-induced nephropathy 10. Hyperthyroidism 11. Pheochromocytoma 12. Sickle cell disease 13. Urinary retention or incontinence 14. Status post organ transplant 15. Pregnancy or active breast feeding 16. Cognitive impairment with inability to give consent 17. Institutionalized status

Design outcomes

Primary

MeasureTime frameDescription
Change in glomerular filtration rate after ingestion of proteinSingle full-day clinic visit: Repeated glomerular filtration rate measurements are to be performed over the course of the day at a single study visit for each participant.Short term-changes in the glomerular filtration rate will be measured before and after ingestion of oral protein

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026